Study of the effect of dexmetedomidine on the outcome of patients with septic shock admitted to the intensive care unit, a randomized single blind placebo controlled trial
Study of the effect of dexmetedomidine on the outcome of patients with septic shock admitted to the intensive care unit
Design
In this research, which designed a parallel single-blind randomized clinical trial, 66 eligible patients randomize to receive one of the interventions. A code is allocated to each participants
Settings and conduct
This study is conducted in the intensive care unit of Imam Khomeini and Razi educational hospital in Sari and Qaemshahr respectively between 2018-19. The patient and register person are blind to the interventions.
Participants/Inclusion and exclusion criteria
The criteria for entering this study are patients with septic shock aged over 18 years who are treated with norepinephrine or vasopressor. Exclusion criteria include patients with uncontrolled diabetes mellitus, patients with grade 2 and 3 ventricular block, patients with sick sinus syndrome, patients with COPD history (arterial oxygen demand below 60 mmHg), patients with history of beta-blockers, patients with hypovolemia And patients with severe liver failure.
Intervention groups
The intervention group will receive Dexmedetomidine 0.8 microgram/kg/hr up to 12 hours.In control group Normal Saline 6cc/kg/hr will start for 12 hours.
Main outcome variables
Improvement of the patient's clinical symptoms (within 12 hours of infusion and 7 days later) include: viability of the patient, separation from the ventilator, reduction of delirium levels, improvement of systolic and diastolic blood pressure and heart rate, reduction of the dose required for epinephrine and morphine and midazolam
General information
Reason for update
Acronym
MICUS
IRCT registration information
IRCT registration number:IRCT20100107003014N22
Registration date:2019-02-25, 1397/12/06
Registration timing:registered_while_recruiting
Last update:2019-02-25, 1397/12/06
Update count:0
Registration date
2019-02-25, 1397/12/06
Registrant information
Name
Shahram Ala
Name of organization / entity
Mazandaran University of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 15 1354 3083
Email address
sala@mazums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-07-23, 1397/05/01
Expected recruitment end date
2019-09-21, 1398/06/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Study of the effect of dexmetedomidine on the outcome of patients with septic shock admitted to the intensive care unit, a randomized single blind placebo controlled trial
Public title
effect of dexmedetomidine on the outcome of septic shock patients
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Patients with septic shock
patients treated with norepinephrine or vasopressor
Patients over the age of 18 years
Exclusion criteria:
uncontrolled diabet melitus
patients with severe hepatic failure
hypovolemic patients
patients with a history of beta blocker use
patients with a history of COPD
patients with sick sinus syndrome
patients with heart block 2,3
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
Outcome assessor
Data analyser
Sample size
Target sample size:
66
Randomization (investigator's opinion)
Randomized
Randomization description
patients will be divided into two groups by block randomization allocation with random table number. Each patient will be given a dedicated code.33 patients will be in the control group and 33 patients will be in the recipient group.
Blinding (investigator's opinion)
Single blinded
Blinding description
The investigator who register patient's hemodynamic changes, is blind to which patients receive which intervention.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
ethics.research.ac.ir
Street address
Moalem Sq
City
Sari
Province
Mazandaran
Postal code
33971-48157
Approval date
2019-02-20, 1397/12/01
Ethics committee reference number
IR.MAZUMS.REC.1397.249
Health conditions studied
1
Description of health condition studied
Septic shock
ICD-10 code
R57.8
ICD-10 code description
Other shock
Primary outcomes
1
Description
clinical success
Timepoint
Every hour to 12 hours and then 7 days after intervention
Method of measurement
Data collecting form
Secondary outcomes
1
Description
Heart rate changes
Timepoint
Every hour up to 12 hours
Method of measurement
Recorder monitor
2
Description
Mean arterial pressure changes
Timepoint
Every hour up to 12 hours
Method of measurement
Recorder monitor
3
Description
Systolic blood pressure changes
Timepoint
Every hour up to 12 hours
Method of measurement
Recorder monitor
4
Description
Diastolic blood pressure changes
Timepoint
Every hour up to 12 hours
Method of measurement
Recorder monitor
5
Description
Norepinephrine dose
Timepoint
Every hour up to 12 hours
Method of measurement
Data collecting form
6
Description
Morphine dose
Timepoint
Every hour up to 12 hours
Method of measurement
Data collecting form
7
Description
Midazolam dose
Timepoint
Every hour up to 12 hours
Method of measurement
Data collecting form
8
Description
SOFA score
Timepoint
Prime of entrance and 7days later
Method of measurement
Data collecting form
9
Description
GCS
Timepoint
Prime of entrance
Method of measurement
Data collecting form
10
Description
APACHE II
Timepoint
Prime of entrance
Method of measurement
Data collecting form
11
Description
Delirium
Timepoint
Prime of entrance
Method of measurement
Data collecting form
12
Description
Dependence on ventilator
Timepoint
7days after intervention
Method of measurement
Data collecting form
13
Description
Survival of patients
Timepoint
7 days after intervention
Method of measurement
Data collecting form
Intervention groups
1
Description
Intervention group: Dexmedetomidine 0.8 micro/kg/h for 12 hours
Category
Treatment - Drugs
2
Description
Control group: Serum Normal saline 6 cc/kg/hr up to 12 hr
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Imam Khomeini hospital
Full name of responsible person
Shahram Ala
Street address
Razi street
City
Sari
Province
Mazandaran
Postal code
3313148166
Phone
+98 11 6333 1700
Email
info@emamhospital.ir
Web page address
2
Recruitment center
Name of recruitment center
Razi hospital
Full name of responsible person
Shahram Ala
Street address
Yoosef Reza street
City
Qaemshahr
Province
Mazandaran
Postal code
4765686743
Phone
+98 11 4221 8018
Email
razi-ghh@mazums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Majid saeedi
Street address
Moallem square, Vice chancellor for research and Technology of Mazandaran University of Medical Sciences,
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3325 7230
Email
pajooheshi@mazums.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Sari University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Shahram Ala
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Payambar Azam University Complex, Mazandaran University of Medical Sciences, Faculty of Pharmacy, Km 18 Khazar Abad Road, Sari, Mazandaran,
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3354 3083
Email
sala@mazums.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Shahram Ala
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
Payambar Azam University Complex, Mazandaran University of Medical Sciences, Faculty of Pharmacy, Km 18 Khazar Abad Road, Sari, Mazandaran
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3354 3083
Email
sala@mazums.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Mazandaran University of Medical Sciences
Full name of responsible person
Shahram Ala
Position
Professor
Latest degree
Specialist
Other areas of specialty/work
Medical Pharmacy
Street address
18km Khazar Abad Road,Payambar Azam University Complex, Mazandaran University of Medical Sciences, Faculty of Pharmacy
City
Sari
Province
Mazandaran
Postal code
4815733971
Phone
+98 11 3354 3083
Email
sala@mazums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available